Generics

Perrigo receives tentative FDA approval for generic Prandin

Generics/News | Posted 09/08/2013

US-based drugmaker Perrigo Company (Perrigo) announced on 19 July 2013 that it had received tentative approval from FDA for its abbreviated new drug application (ANDA) for repaglinide tablets.

Indian generics companies top ANDA approvals

Generics/General | Posted 09/08/2013

Indian generics companies are beating many other countries when it comes to gaining US FDA approval for their generic drugs.

Use of brand-name drugs increasing healthcare costs in US

Generics/Research | Posted 02/08/2013

Patients with diabetes who are covered by the US healthcare insurance Medicare are two to three times more likely to use expensive brand-name drugs compared to patients treated within the Veterans Affairs Healthcare System [1].

Teva loses fight against generic glatiramer acetate

Generics/News | Posted 02/08/2013

On 26 July 2013 the US Federal Circuit Court of Appeals invalidated several of Teva’s patents on Copaxone (glatiramer acetate), including one that protected the drug until September 2015.

Generics combo non-inferior to treatment with Enbrel

Generics/Research | Posted 05/07/2013

A study carried out by researchers from the US Department of Veterans Affairs and the Canadian Institutes for Health Research has found that a combination of three generic drugs is non-inferior to treatment with Amgen’s blockbuster biological Enbrel (etanercept) [1].

Generics applications under review by EMA – 2013 Q2

Generics/General | Posted 05/07/2013

Last update: 6 September 2013

Generic medicines in Europe can be approved either centrally via the European Medicines Agency (EMA) or nationally via the local regulatory body [1]. Approval by EMA takes place by using a centralized procedure. This leads to approval of the product in all 27 EU member states and in Norway, Iceland and Liechtenstein. At a country level, if approval in a single EU Member State only is required, this can take place using the national procedure. However, as soon as a company seeks approval in two or more Member States, a decentralized procedure or mutual recognition procedure must be used [2].

Enhancing prescribing efficiency in the Republic of Srpska

Generics/Research | Posted 28/06/2013

It has been claimed that countries with smaller populations have difficulties obtaining considerable price reductions for generics. However, evidence from the Republic of Srpska, which is one of the two constitutive entities of Bosnia and Herzegovina, with a population of only 1.43 million, proves otherwise [1].

Ranbaxy faces lawsuit in India

Generics/News | Posted 28/06/2013

An Indian lawyer has filed a lawsuit asking the Indian Supreme Court to investigate Ranbaxy Laboratories (Ranbaxy), its executives and Indian drug control officers, as well as to shut down two of Ranbaxy’s Indian plants.

Actavis submits ANDAs for two more generics

Generics/News | Posted 21/06/2013

Actavis has filed for US approval for generic versions of a contraceptive and a sedative/anaesthetic.

Teva and Sun Pharma settle battle over generic Protonix

Generics/News | Posted 14/06/2013

Pfizer announced on 12 June 2013 that the pharma giant had reached a settlement with generics manufacturers Teva Pharmaceuticals Industries (Teva) and Sun Pharmaceutical Industries (Sun Pharma) for damages resulting from their ‘at-risk’ launches of generic pantoprazole in the US.

Dr Reddy’s and Fujifilm call off joint venture for generics in Japan

Generics/News | Posted 07/06/2013

Two years after signing a deal to work together on generics in Japan, Fujifilm Corporation (Fujifilm) and Dr Reddy’s Laboratories (Dr Reddy’s) have called off their agreement.

Equivalence of generic immunosuppressants

Generics/Research | Posted 31/05/2013

There are no compelling pharmacological arguments against the sensible use of the generic immunosuppressants ciclosporin, tacrolimus and mycophenolate mofetil in clinical practice, argue pharmacologists working in drug evaluation in The Netherlands [1].

US appeals court halts Pulmicort generics

Generics/News | Posted 31/05/2013

On 25 May 2013, the US Court of Appeals for the Federal Circuit issued a temporary injunction in the US stopping generics of AstraZeneca’s asthma treatment Pulmicort Respules (budesonide inhalation suspension).

Lipitor generics saved UK NHS £350 million in first 12 months

Generics/General | Posted 31/05/2013

Generics of the blockbuster cholesterol-lowering drug Lipitor (atorvastatin) saved the UK’s National Health Service (NHS) more than GBP 350 million in the first 12 months following the expiration of Pfizer’s patent exclusivity.

Ranbaxy pays US$500 million to resolve US litigation

Generics/News | Posted 24/05/2013

In what has been hailed as the largest ever settlement of its kind involving a drug safety settlement with a generics manufacturer, Ranbaxy Laboratories (Ranbaxy) pleaded guilty to violations of the Food, Drug and Cosmetics Act (FDCA) and making false statements.

Sanofi fined for discouraging generic clopidogrel prescriptions

Generics/News | Posted 17/05/2013

On 14 May 2013, French drugmaker sanofi-aventis was fined Euros 40.6 million by the French competition authority (L’Autorité de la concurrence) for marketing practices that discouraged sales of generic versions of its blood thinner Plavix (clopidogrel).

FDA rejects Endo petition to stop Opana ER generics

Generics/News | Posted 17/05/2013

On 10 May 2013, FDA announced that it had rejected a petition by Endo Pharmaceuticals (Endo) to stop generics of its powerful painkiller, Opana ER (oxymorphone).

The biggest drug patent losses for 2013

Generics/General | Posted 17/05/2013

During 2012–2018 over US$290 billion of sales are at risk from patent expirations. In fact, in 2013 alone patents will expire on drugs with yearly sales of US$29 billion. Generics are expected to grab 70% of those sales.